SpyGlass in Post Liver Transplant Biliary Complications.

Not Applicable

Completed

• Conditions: Biliary Anastomosis Complication; Liver Transplant Disorder
• Interventions: Procedure: SpyGlass (direct visualization system) choledochoscopy

• Registration Number: NCT02543151
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

The purpose of this study is to describe SpyGlass choledochoscopy in patients with post orthotopic liver transplant (OLT) biliary strictures prior to endoscopic therapy and ductal changes after treatment stents.

Detailed Description

A prospective observational clinical study to be conducted in Hospital Israelita Albert Einstein, a large open-access, private tertiary referral center.

Consecutive eligible patients with suspected post OLT biliary complications referred to endoscopic retrograde cholangiopancreatography (ERCP) will be considered to SpyGlass as follows.

In those patients with confirmed biliary stricture, SpyGlass direct choledochoscopy will be performed prior to endoscopic treatment with stents.

After final stent removal, choledochoscopy will be repeated to evaluate biliary ductal mucosa.

Study Timeline

• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Study Start: 2016-03
• Primary Completion: 2017-06
• Study Completion: 2018-10
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients referred to endoscopic management for biliary post liver transplant complication without previous treatment

Exclusion Criteria

• Patients referred to endoscopic management for biliary post liver transplant complication with any previous treatment.
• Below 18 years of age
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SpyGlass Choledochoscopy procedure	SpyGlass (direct visualization system) choledochoscopy	Any patient referred to endoscopic management for biliary post liver transplant complication without previous treatment will be submitted to SpyGlass (direct visualization system) choledochoscopy procedure.

Primary Outcome Measures

Name	Time	Method
Documentation of biliary ductal changes in post-liver transplant biliary complications.	2 years	The study aim is to describe biliary ductal changes in post-liver transplant presenting biliary complications

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events.	2 years	Secondary outcomes include the description of adverse events

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, SP, Brazil